LINK Endo-Model EVO 15-5605/12
GUDID 04026575278084
Modular Stem, Conical Cemented Stem, 6 mm Offset
WALDEMAR LINK GmbH & Co. KG
Knee femur stem prosthesis| Primary Device ID | 04026575278084 |
| NIH Device Record Key | dec32116-ae19-419f-8070-aacc939af28c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LINK Endo-Model EVO |
| Version Model Number | 15-5605/12 |
| Catalog Number | 15-5605/12 |
| Company DUNS | 315675488 |
| Company Name | WALDEMAR LINK GmbH & Co. KG |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04026575278084 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202924
FDA Product Code
| HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-15 |
| Device Publish Date | 2021-10-07 |
On-Brand Devices [LINK Endo-Model EVO]
| 04026575301669 | Modular Stem, Cylindrical |
| 04026575301645 | Modular Stem, Cylindrical |
| 04026575301621 | Modular Stem, Cylindrical |
| 04026575301607 | Modular Stem, Cylindrical |
| 04026575301584 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575301560 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575301546 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575301522 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575301508 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575301485 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575301461 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575301447 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575301423 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575301409 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575301386 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575286218 | Replacement Set for Cone Adapter |
| 04026575286195 | Replacement Set for Cone Adapter |
| 04026575286164 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575286157 | Modular Stem, Conical Cemented Stem |
| 04026575286140 | Modular Stem, Conical Cemented Stem |
| 04026575284801 | Modular Stem, Conical Cemented Stem |
| 04026575278381 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575278374 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575278350 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575278336 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575278169 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575278107 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575278084 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575278060 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575278053 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575277919 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575277896 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575277872 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575277865 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575277827 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575277803 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575277797 | Modular Stem, Conical Cemented Stem, 6 mm Offset |
| 04026575277780 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575277773 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575277766 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575277759 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575277735 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575277728 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575277711 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575277490 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575277124 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575276448 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575276370 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575276325 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
| 04026575276219 | Modular Stem, Conical Cemented Stem, 3 mm Offset |
Trademark Results [LINK Endo-Model EVO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LINK ENDO-MODEL EVO 79298975 not registered Live/Pending |
Waldemar Link GmbH & Co. KG 2020-09-03 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.